Trauma Treatment + PrEP Navigation for Mental Health Symptoms

Overseen By Benji Jensen, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Must be taking: PrEP

Disqualifiers: Under 18, Cognitive impairment, Violence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 33

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot trial will leverage "PrEP Well," an ongoing multi-level implementation strategy for providing PrEP in transgender/gender diverse (TGD)-serving contexts by integrating peer-led PrEP navigation with programming that addresses other social and structural needs of the TGD community (e.g., housing, legal, employment, gender-affirmation, primary care). PrEP Well has been implemented at the Trans Wellness Center (TWC) in LA since 2021. TWC is a first-of-its-kind community-led, trans-affirming, TGD community center made up of 5 community-based TGD service organizations that serve the local racially and ethnically diverse TGD community. Together with our community and implementation partners this NIMH-funded R34 will adapt evidence-based Skills Training in Affect and Interpersonal Regulation (STAIR) into a trans-affirming, culturally appropriate trauma treatment for TGD persons affected by HIV and violence (Trans STAIR); evaluate the acceptability, appropriateness, and feasibility of the Trans STAIR intervention (Phase 1 beta test; Aim 1); and conduct a Type 1: Hybrid Effectiveness-Implementation pilot randomized controlled trail (Phase 2 pilot RCT; Aims 2 and 3) of PrEP Well + Trans STAIR vs. PrEP Well alone to provide preliminary support for a fully powered larger multisite R01 to test the efficacy of PrEP Well + Trans STAIR.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment PrEP Well, Trans STAIR for mental health symptoms?

Research shows that collaborative care models, which include follow-up assessments and referrals, can improve mental health outcomes for trauma patients. Additionally, technology-enhanced interventions have been associated with modest reductions in PTSD symptoms, suggesting that similar approaches may be beneficial for mental health symptoms in trauma patients. ^{1 2 3 4 5}

Is the Trauma Treatment + PrEP Navigation for Mental Health Symptoms generally safe for humans?

The studies reviewed focus on treatments for PTSD, including prolonged exposure therapy and ketamine infusions, which have been evaluated for safety. Prolonged exposure therapy is generally considered safe, though it may cause temporary distress as individuals confront traumatic memories. Ketamine infusions have shown preliminary safety in trials, but more research is needed to confirm their safety for PTSD treatment. ^{5 6 7 8 9}

How does the treatment Trauma Treatment + PrEP Navigation for Mental Health Symptoms differ from other treatments for PTSD?

This treatment is unique because it combines trauma-focused therapy with PrEP (pre-exposure prophylaxis) navigation, addressing both mental health symptoms and HIV prevention, which is not a standard approach in PTSD treatments. It also potentially reduces barriers to care by integrating telemedicine, making it more accessible for those who face logistical or stigma-related challenges. ^{10 11 12 13 14}

Research Team

Erik Storholm, PhD

Principal Investigator

San Diego State University

Eligibility Criteria

This trial is for transgender/gender diverse individuals affected by HIV and violence. Participants should be interested in a program that combines peer-led PrEP navigation with support for social needs like housing and employment, provided at the Trans Wellness Center in LA.

Inclusion Criteria

Report not currently in a relationship or home where violence is occurring (participants will be referred to LGBT Center's STOP Violence Program)

Confirmed HIV-negative status

I identify as transgender or nonbinary.

Exclusion Criteria

Anyone who does not meet the above criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Beta Test

Preliminary test of Trans STAIR with 20 PrEP Well participants to evaluate acceptability, appropriateness, and feasibility

90 days

Multiple visits for interviews and feedback

Phase 2 Pilot RCT

Pilot randomized controlled trial of PrEP Well + Trans STAIR vs. PrEP Well alone with 70 participants

90 days

3 sessions of PrEP Well, 8 sessions of Trans STAIR

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Follow-up visits at 30-day and 90-day intervals

Treatment Details

Interventions

• PrEP Well
• Trans STAIR

Trial Overview The study tests 'Trans STAIR', a trauma treatment adapted for the TGD community, alongside 'PrEP Well', which helps with PrEP adherence. It's to see if combining these improves mental health, wound healing, and PrEP use compared to just 'PrEP Well'.

Participant Groups

Group I: PrEP Well + Trans STAIR Experimental Treatment 2 Interventions

Participants assigned to this condition will be enrolled in 3 sessions of PrEP Well + 8 sessions of Trans STAIR over 90 days. PrEP Well is a multi-level implementation strategy for providing PrEP in TGD-serving contexts by integrating peer-led PrEP navigation with programming that addresses other social and structural needs of the TGD community (e.g., housing, legal, employment, gender-affirmation, primary care). Trans STAIR (Experimental Treatment) Skills Training in Affect and Interpersonal Regulation (STAIR) adapted for TGD is 8-session, group delivery of transdiagnostic evidenced-based treatment for individuals who have experienced multiple traumas. STAIR is based in cognitive-behavioral principles and delivered in a flexible manner, with demonstrated efficacy for the treatment of PTSD, depression and other mental health symptoms known to be associated with poor medication adherence.

Group II: PrEP Well Active Control 1 Intervention

Participants assigned to this condition will be enrolled in 3 sessions of PrEP Well over 90 days, PrEP Well is a multi-level implementation strategy for providing PrEP in TGD-serving contexts by integrating peer-led PrEP navigation with programming that addresses other social and structural needs of the TGD community (e.g., housing, legal, employment, gender-affirmation, primary care).

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

Los Angeles LGBT Center

Collaborator

Trials

8

Recruited

1,600+

RAND

Collaborator

Trials

145

Recruited

617,000+

Findings from Research

A pragmatic clinical trial involving 121 acutely injured trauma survivors showed that an IT-enhanced collaborative care intervention for PTSD resulted in modest symptom reductions, particularly significant at 3 and 6 months post-injury.

The intervention required a median of only 2.25 hours per patient, suggesting that this model could provide an efficient way to deliver PTSD treatment without extensive clinical resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial. Zatzick, D., O'Connor, SS., Russo, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Screening and treating hospitalized trauma survivors for posttraumatic stress disorder and depression. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Blanchfield Army Community Hospital Polypharmacy Clinic. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A proof-of-concept randomized controlled trial of follow-up mental health care for traumatic injury patients following hospital discharge. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A randomized stepped care intervention trial targeting posttraumatic stress disorder for surgically hospitalized injury survivors. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Innovative service delivery for secondary prevention of PTSD in at-risk OIF-OEF service men and women. [2013]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Prolonged exposure, paroxetine and the combination in the treatment of PTSD following a motor vehicle accident. A randomized clinical trial - The "TRAKT" study. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Trauma Management Therapy and Prolonged Exposure Therapy for PTSD in an active duty sample: Design and methodology of a randomized clinical trial. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Repeated ketamine infusions for antidepressant-resistant PTSD: Methods of a multicenter, randomized, placebo-controlled clinical trial. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of in-person vs. home-based telemedicine delivery of Prolonged Exposure for PTSD in military sexual trauma survivors. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Best Practices for Approaching Cognitive Processing Therapy and Prolonged Exposure During the COVID-19 Pandemic. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

"Do you expect me to receive PTSD care in a setting where most of the other patients remind me of the perpetrator?": Home-based telemedicine to address barriers to care unique to military sexual trauma and veterans affairs hospitals. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

An intensive outpatient treatment program for combat-related PTSD: Trauma Management Therapy. [2018]

14. Australia pubmed.ncbi.nlm.nih.gov

Treating adults with acute stress disorder and post-traumatic stress disorder in general practice: a clinical update. [2022]